Systems and methods for anchoring medical devices

ABSTRACT

Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter) in place relative to a skin penetration point using subcutaneous anchors.

CLAIM OF PRIORITY

This application is a continuation and claims priority to U.S. patentapplication Ser. No. 13/649,688, filed on Oct. 11, 2012, the entirecontents of which are hereby incorporated by reference.

TECHNICAL FIELD

This document relates to devices, systems, and methods for securing theposition of a catheter or another medical instrument, for example, at askin opening.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Alternatively, catheters can containelectrical leads for neuro-stimulation, cardiac pacing, and the like.Following introduction into the patient, the catheter is secured to thepatient. In many instances, the catheter is commonly secured to thepatient using an adhesive tape on the skin or by suturing a catheter hubto the patient's skin. In other circumstances, the catheter may besecured to the patient using a subcutaneous anchor mechanism (such as ananchor sleeve equipped with anchors that are deployed using an externalactuator handle or a separate delivery device). In many cases, themedical practitioner will make efforts to clean the skin area around thecatheter insertion site for purposes of a patient's comfort, safety, andimproved visualization of the catheter insertion site after the catheteris installed.

SUMMARY

Some embodiments of a medical device anchor system include an anchordevice that receives a medical instrument (such as a catheter or thelike that is optionally equipped with suture wings) and secures theinstrument in place relative to a skin penetration point. For example,the medical anchor device can be configured to releasably mate thesuture wings on a hub of a catheter while also providing subcutaneousanchor mechanisms deployable through the skin penetration point that isalready occupied by the catheter, thereby reducing or eliminating theneed for installing sutures through the suture wings and the patient'sskin. Optionally, in some embodiments the anchor device can be adjustedto a folded configuration that aligns the tines of the subcutaneousanchors in a generally side-by-side configuration to facilitateinsertion of the anchors through the skin penetration point. Such aconfiguration may allow the anchor device to be installed after medicalinstrument is already in place without the need for a second penetrationpoint for the anchor device. In particular embodiments, the anchordevice may be configured to simplify the use of the anchor device, makethe anchor device more adaptable to use with medical instruments ofdifferent sizes, and to facilitate the maintenance and cleaning of theskin tissue at and around the skin penetration point.

Some embodiments described herein include an anchor device for securingthe position of a medical instrument. The anchor device may include aretainer body and first and second anchors extending from the retainerbody. Optionally, the retainer body may include a first body portionthat is pivotably coupled to a second body portion about a longitudinalfold axis. Also, the retainer body may optionally include one or moreanchor engagement portions that are configured to releasably receive oneor more corresponding apertures defined by a hub of a catheter. Thefirst and second anchors may optionally extend distally from a distalend of the retainer body. Each anchor may include a flexible tine thatis deployable in a subcutaneous region to secure the retainer bodyrelative to a penetration point. The first anchor may be coupled to thefirst body portion and the second anchor may be coupled to the secondbody portion. Optionally the first body portion of the retainer body maybe pivotable relative to the second body portion about the longitudinalfold axis so that the first and second anchors are adjustable from afirst configuration in which the flexible tines extend outwardly awayfrom one another to a second configuration in which the flexible tinesextend generally in the same direction.

Particular embodiments described herein include an anchor device forsecuring the position of a medical instrument. The anchor device mayinclude a retainer body comprising a first body portion that ispivotably coupled to a second body portion about a longitudinal foldaxis. The retainer body may also include one or more anchor engagementportions being configured to mate with an external structure of amedical instrument to releasably secure the medical instrument to theretainer body. The anchor device may further include first and secondanchors that extend distally from a distal end of the retainer body.Each anchor comprising a flexible tine that is deployable in asubcutaneous region to secure the retainer body relative to apenetration point. The first anchor may be coupled to the first bodyportion, and the second anchor may be coupled to the second bodyportion. The first body portion of the retainer body may be pivotablerelative to the second body portion about the longitudinal fold axis sothat the first and second anchors can be adjusted from a firstconfiguration in which the flexible tines extend outwardly away from oneanother to a second configuration in which the flexible tines extendgenerally in the same direction.

Further embodiments described herein include a system for securing theposition of a medical instrument. The system may include an adapter andan anchor device. The adapter may include a hub portion that iselastically deformable and configured to substantially surround andreleasably engage with the outer surface of medical instrument. Theadapter may also include a second portion having one or more engagementmembers extending outwardly from the hub portion. The anchor device mayinclude a retainer body comprising a first body portion that ispivotably coupled to a second body portion. The anchor device may alsoinclude one or more anchor engagement portions being configured toreleasably couple with the one or more engagement members extendingoutwardly from the hub portion of the adapter. The anchor device mayfurther include first and second anchors that extend distally from adistal end of the retainer body. Each anchor may include a flexible tinethat is deployable in a subcutaneous region to secure the retainer bodyrelative to a penetration point. The first anchor may be coupled to thefirst body portion, and the second anchor may be coupled to the secondbody portion. The first body portion of the retainer body may bepivotable relative to the second body portion so that the first andsecond anchors are adjustable from one another to a removalconfiguration in which the flexible tines extend generally in the samedirection.

Some other embodiments described herein may include a kit of componentsfor securing the position of a catheter relative to a penetration point.The kit may include a sterile package containing two or more adaptershaving a hub portion with differently shaped or sized longitudinallumens. Each of the two or more adapters in the sterile package maycomprise an elastically deformable material to permit access to therespective longitudinal lumen. Also, each of the two or more adapters inthe sterile package may include a one or more flanges extendingoutwardly away from the hub portion. The hub portion may include alongitudinal slit through a wall portion to permit access to therespective longitudinal lumen. The one or more flanges may each includean adapter engagement portion configured to releasably engage withretention posts of an anchor device.

Additional embodiments described herein may include a kit of componentsincluding a sterile package containing an anchor device and a catheter.The catheter may include a hub having one or more apertures configuredto releasably mate with the anchor device. The anchor device may includea retainer body including a first body portion that is pivotably coupledto a second body portion. The retainer body may also include one or moreanchor engagement portions being configured to releasably couple withone or more corresponding catheter engagement portions on a hub of thecatheter. The anchor device may further include first and second anchorsthat extend distally from the retainer body. Each anchor may include aflexible tine that is deployable in a subcutaneous region to secure theretainer body relative to a penetration point. The first anchor may becoupled to the first body portion, and the second anchor may be coupledto the second body portion. The first body portion of the retainer bodymay be pivotable relative to the second body portion so that the firstand second anchors are adjustable from one another to a removalconfiguration in which the flexible tines extend generally in the samedirection.

Particular embodiments described herein may include a method of using amedical anchor system. The method may include advancing an anchor devicetoward a skin penetration point while the anchor device is in a foldedcondition so that a plurality of subcutaneous tines of the anchor deviceare generally adjacent to each other and oriented to extend insubstantially the same direction. The method may also include insertingthe subcutaneous tines through the skin penetration point and into asubcutaneous region adjacent to an underside of a skin layer while theanchor device is in the folded condition. Each of the subcutaneous tinesmay have a shape (optionally, a curved shape) which terminates at a tipof a free end during insertion through the skin penetration point. Themethod may further include adjusting the anchor device to a non-foldedcondition after the subcutaneous tines are inserted into thesubcutaneous layer so that subcutaneous tines are in an anchoredposition in which the free ends of the subcutaneous tines extendgenerally away from one another. The method may include securing amedical instrument to the anchor device after the subcutaneous tines areadjusted to the anchored position in the subcutaneous region. Thesecuring operation may include coupling one or more protrusionsextending from the anchor device with one or more apertures located onthe medical instrument.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor system can retain amedical instrument in a desired position relative to a skin penetrationpoint without necessarily requiring sutures or skin adhesives. Second,particular embodiments of the anchor device may be readily adaptable touse with catheters or other medical instruments of different sizes,while also securing the catheter or medical instrument to a skinpenetration point in a manner that facilitates improved inspection andcleaning of the skin tissue at and around the skin penetration point.For example, some of these particular embodiments of the anchor devicecan provide a capless design in which the anchor device releasablycouples with an external portion of the catheter or medical devicewithout the need for an attachable cap device, thereby simplifying theprocess for a practitioner to inspect and clean the anchor device andthe skin surface near the skin penetration point. Third, in someembodiments, the anchor device may be adjusted between a foldedconfiguration and a non-folded configuration so that the subcutaneousanchors are arranged side-by-side and extend in generally the samedirection during both installation through and removal from the skinpenetration point. Fourth, in some embodiments, the anchor device can beinstalled in accordance with a technique that reduces or eliminates theneed to shift the subcutaneous anchors tines to or from a flexed orstressed configuration. Thus, in these embodiments, the subcutaneousanchors may be readily installed and removed from the skin penetrationwithout the need for a separate external actuator or delivery device.Fourth, in some embodiments, the configuration of the anchor device cansimplify the process of installing a medical instrument onto the anchordevice. Sixth, in some embodiments, the anchor device can be configuredto be usable with a variety of styles and sizes of medical instruments.Seventh, in some embodiments, the anchor device can enable a hub of acatheter or other medical instrument to be positioned in close proximityto the skin penetration point.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor device with a portion of thedevice located in a subcutaneous region, in accordance with someembodiments.

FIGS. 2A-2C are perspective, side, and rear views, respectively, of theanchor device of FIG. 1.

FIGS. 3A-3B are a perspective and top view, respectively, of the anchordevice of FIG. 1 in a folded condition, in accordance with someembodiments.

FIGS. 4, 5, and 6A-B are perspective views of an anchor system,including the anchor device of FIG. 1, for use in securing the positionof a medical instrument.

FIGS. 7A-7C are perspective views of shaft lock accessory for use withthe anchor device of FIG. 1, for use in securing the position of amedical instrument.

FIG. 8 is a perspective view of the anchor device of FIG. 1 coupled withthe shaft lock accessory of FIGS. 7A-7C in a deployed configuration.

FIG. 9 is a perspective view of an anchor device in accordance with somealternative embodiments.

FIG. 10 is a perspective view of an anchor system, including analternative embodiment of an anchor device.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a medical device anchor system10 include an anchor device 100 that releasably retains a medicalinstrument 20 in an operative position relative to a portion of skin 30.The medical instrument 20 can be mechanically coupled to the anchordevice 100. The anchor device 100, in turn, can be coupled to theportion of skin 30. In this manner, the anchor device 100 can act as anintermediary member to cause the retention of the medical instrument 20in a desired position with respect to the skin 30. The exampleembodiment of FIG. 1, can include a central venous catheter 20 insertedthrough a percutaneous opening formed in the skin (e.g., penetrationpoint 32), proceeding to the underside of the skin 30, and into a vein40 to provide vascular access for delivering medications, withdrawingfluids, or providing minimally invasive access into a patient.

In this example, the anchor device 100 can generally include a retainerbody 110 and one or more anchors 140 a-b that extend distally from adistal end of the retainer body 110. As described further below, theretainer body 110 can be configured to couple with the medicalinstrument 20. The one or more anchors 140 a-b can be configured fordeployment through a skin penetration point 32 and into in asubcutaneous layer 34, so as to releasably retain the anchor device 100with respect to the skin 30. For example, the retainer body 110 caninclude the one or more anchors 140 a and 140 b that extend distallyfrom the retainer body 110 so as to penetrate through the same skinpenetration point 32 as the medical instrument 20 while the retainerbody 110 remains external to the skin penetration point. In someembodiments, the skin penetration point 32 may be defined by a smallincision, a puncture, or the like through the dermal layers 36.

The anchors 140 a-b can include subcutaneous tines 145 a-b that, afterinsertion, reside in a subcutaneous region 34 (e.g., a regionimmediately under the skin 30 that may comprise a fatty tissue layer) soas to secure the position of the anchor device—and the medicalinstrument 20 retained therein—relative to the penetration point 32.When the tines 145 a-b are deployed in the subcutaneous region 34, theanchor device 100 can be secured to the patient without the retainerbody 110 penetrating through the dermal layers 36 of the patient, andwithout necessarily requiring sutures or adhesive tapes bonded to theskin 30.

As described in more detail below in connection with FIGS. 4-6B, theanchor device 100 can be installed into a skin penetration point 32 inaccordance with a technique that reduces or eliminates the need to shiftthe subcutaneous anchors tines 145 a-b of the anchors 140 a-b to or froma flexed or stressed configuration. As such, the anchor tines 145 a-bneed not undergo substantial flexing during installation or removal. Inthese circumstances, the subcutaneous anchors may be both installed andremoved from the skin penetration point 32 advantageously without theneed for an external actuator handle or delivery device to deploy thesubcutaneous tines 145 a-b.

Still referring to FIG. 1, after installation of the subcutaneous anchortines 145 a-b into the subcutaneous layer 34, the retainer body 110 canreceive the medical instrument 20. In this example, the medicalinstrument 20 is embodied as a catheter. Hence, hereinafter the medicalinstrument 20 may alternatively be referred to as catheter 20, withoutlimiting the medical instrument 20 to such an embodiment. Furthermore,in some embodiments, the anchor device 100 can provide a capless designin which the anchor device 100 releasably couples with an externalportion of the catheter 20 without the need for attaching a cap onto theretainer body 110, thereby simplifying the process inspecting andcleaning the anchor device 100 and the skin surface near the skinpenetration point 32 after installation.

In this embodiment, the example catheter 20 generally includes aproximal portion 26, a hub 22, and a distal portion 28. The hub 22 caninterconnect the proximal portion 26 with the distal portion 28. In someembodiments, the proximal portion 26 of the catheter 20 may havemultiple lumens that are suited to deliver multiple types of solutionsto the patient. In some such embodiments, the hub 22 can receive themultiple lumens on the proximal end of the hub 22, and merge themultiple lumens so as to connect with a single lumen distal portion 28.For example, as shown in FIG. 1, the proximal portion 26 is depicted ashaving two lumens, and the distal portion 28 as having a single lumenthat is adapted for percutaneous insertion through skin penetrationpoint 32. Hence, the hub 22 can serve the purpose of merging multipleproximal supply lumens into a single distal delivery lumen suited forinsertion into the patient.

The hub 22 can further be arranged to couple the catheter 20 onto theanchor device 100. In some embodiments, the hub 22 can include wings 24a-b. The wings 24 a-b can have features that facilitate the coupling ofthe hub 22 to the anchor device 100. For example, some embodiments ofthe hub 22 can include apertures 26 a-b in the wings 24 a-b. Theapertures 26 a-b can be located and sized to couple with correspondingfeatures of the anchor device 100 (e.g., retention posts 112 a-b asfurther described in reference to FIGS. 2A-C). In addition, the hub 22can be manufactured from an elastomeric or otherwise flexible material,such as silicone or another biocompatible polymer material (e.g., PVC,polypropylene, polystyrene, or the like). In some embodiments, the hub22 can be made from a combination of materials. For example, at leastwings 24 a-b may comprise silicone or another flexible biocompatiblematerial so that the wings 24 a-b and the apertures 26 a-b can flexiblyadjust to couple with the retention posts 112 a-b of the anchor device100, whereas the portions of the hub 22 other than the wings 24 a-b maycomprise a more rigid polymer material. As will be described further inreference to FIGS. 5 and 6B, such flexibility of the wings 24 a-b canassist the user in coupling the hub 22 to the anchor device 100 as itrelates to aligning the apertures 26 a-b with the retention posts 112a-b, and forcing the apertures 26 a-b over the mushroom-shaped heads ofthe retention posts 112 a-b. Such flexibility of the wings 24a-bsimilarly assists with decoupling the hub 22 from the anchor device100.

Referring now to FIGS. 2A-2B, some embodiments of the anchor device 100include the retainer body 110 and the anchors 140 a-b, which areconnected to and extend distally from the distal end of the retainerbody 110. For example, the anchors 140 a and 140 b can be connected tothe retainer body 110 using an over-molding process to secure theanchors 140 a-brelative to the retainer body 110. It should also beunderstood that there exist many manufacturing processes that can securethe anchors 140 a and 140 b to the retainer body 110. In someembodiments, the retainer body 110 and the anchors 140 a and 140 bcan bemanufactured as a single, unitary piece.

in particular embodiments, the anchor device 100 can be configured to befolded longitudinally about a longitudinal fold axis 160 (e.g., alongitudinally extending region configured for enabling the retainerbody 110 to repeatedly adjust from a first position to a second, foldedposition as shown, for example, in FIGS. 3A-3B). Consequently, theretainer body 110 can be described as having a first retainer bodyportion 120 a and a second retainer body portion 120 b. In someembodiments, the first and second retainer body portions 120 a-b can besubstantially mirror images of each other. In alternative embodiments,the first and second portions of the anchor device 100 can beasymmetrical.

Preferably, at least a portion of each anchor 140 a-b comprises aflexible material. In some embodiments, the anchors 140 a-b may comprisea material that exhibits superelasticity. In some embodiments, at leasta portion of the anchors 140 a-b (including the tines 145 a-b) may beformed from a length of nitinol wire or from a sheet of nitinolmaterial. Alternatively, the anchors 140 a-b may comprise a metalmaterial such as stainless steel (e.g., 304 stainless, 316 stainless,custom 465 stainless, and the like), spring steel, titanium, MP35N, andother cobalt alloys, or the like. In another alternative, the anchors140 a-b may be formed from a resilient polymer material. In someembodiments, the anchors 140 a-b can be formed from a material ormaterials that allow the tines 145 a-b to be flexed and can resilientlyreturn to an unstressed position.

In the embodiment depicted in FIGS. 2A-C, each of the anchors 140 a-bmay be designed such that the tines 145 a-b have an unstressed positionwherein the tines 145 a-b have a convex curvature. The convex curvatureshape of the tines 145 a-b may permit the tines 145 a-b to abut againstthe underside of the dermal layers 36 in a manner that reduces thelikelihood of the tine tips 146 puncturing the underside of the dermallayers 36. Preferably, the tine tips 146 are rounded bulbs or otherwisenon-sharp so as to further protect the underside of the dermal layers36. In alternative embodiments, the tines 145 a-b may have a generallystraight shape that extends substantially perpendicular to thelongitudinal shaft portions of the anchors 140 a-b to the rounds tips146.

Still referring to FIGS. 2A-C, the retainer body 110 can include firstand second retainer body portions 120 a-b arranged on opposing sides ofthe longitudinal fold axis 160, retention posts 112 a-b, left and righttabs 122 a-b, and (optionally) a sloped nose region 130. The first andsecond retainer body portions 120 a-b can be connected to each other atan elastically flexible web portion 150, which may be employed to definethe fold axis 160.

The retainer body 110 can comprise one or more biocompatible polymermaterials (e.g., PVC, polypropylene, polystyrene, or the like). In someembodiments, the retainer body 110 can comprise a combination of suchmaterials, for example, when the flexible web portion comprises anelastically flexible silicone material while the first and secondretainer body portions 120 a-b comprise a less flexible polymer materialsuch as polypropylene, PVC, polystyrene, or the like. In someembodiments, the retainer body 110 can be formed using a molding processin which the retainer body 110 is over-molded around a portion of theanchors 140 a-b, especially in those embodiments in which the anchors140 a-b comprise a metallic material. For example, the left retainerbody portion 120 a can be over-molded around a portion of anchor 140 aand, during the same or a different molding process, the right bodyportion 120 b can be over-molded around a portion of anchor 140 b.Consequently, as described further below, when the retainer body 110 isfolded, the respective anchors 140 a-b (being connected to the retainerbody portions 120 a-b respectively) likewise move in conjunction withtheir respective retainer body portion 120 a-b.

Still referring to FIGS. 2A-C, the retention posts 112 a-b can beconfigured to provide an effective coupling interface with a medicalinstrument 20, while providing features that simplify the overall use ofthe medical device anchor system 10. For example, in this embodiment,the retention posts 112 a-b may provide the user with a simplifiedcoupling technique for mating the anchor device 100 to the medicalinstrument 20, and may furthermore do so without the need for anattachable cap device or skin sutures. In the depicted example, theretention posts 112 a-b in general are sized and spaced apart in amanner that is configured, for example, to be coupled with apertures 26a-b located on the wings 24 a-b of the hub 22 of a catheter 20 (refer toFIG. 1). In this embodiment, the retention posts are substantiallyequally spaced from the longitudinal fold axis 160 of the retainer body110. As described in more detail below, the retention posts 112 a-b caninclude generally mushroom-shaped heads 114 a-b, stem portions 116 a-b,and relief portions 118 a-b. In such circumstances, each of theretention posts 112 a-b may have generally asymmetric shape about avertical plane extending through a central vertical axis of eachrespective retention post 112 a-b and extending generally parallel tothe fold axis 160.

As described in more detail below, the shape and position of theretention posts 112 a-b can permit a practitioner to intuitively matethe wings 24 a-b of the catheter 20 (FIG. 1) with the retainer body 110with the need for secondary locking mechanisms such a cap devices thatattach to the retainer body 110, adhesive tapes, or the like. Themushroom-shaped heads 114 a-b can have rounded tops that help the useralign the apertures 26 a-b with their respective retention posts 112a-b. In some embodiments, the mushroom-shaped heads 114 a-b can be sizedto have a low interference fit with the apertures 26 a-b. For example,if the hub 22 of the medical device 20 can comprise an elasticallyflexible material, the user will be readily able to mate the hub 22 tothe retention posts 112 a-b of anchor device 100 by forcibly andtemporarily flexing the apertures 26 a-b over the mushroom-shaped heads114 a-b. Thus, when securing the medical device 20 to the anchor device100, the user can align the apertures 26 a-b with the mushroom-shapedheads 114 a-b and lightly press the hub 22 of the medical device 20against the anchor device 100 so that the apertures 26 a-b pass over andbelow the mushroom-shaped heads 114 a-b. The hub 22 can be pressed ontothe anchor device by engaging one side at a time or by engaging bothsides simultaneously. At that stage, the apertures 26 a-b have passedover the mushroom-shaped heads 114 a-b and surround the stem portions116 a-b of the retention posts 112 a-b, thereby releasably securing thehub 22 of the medical instrument 20 in a position that is adjacent tothe skin penetration point 32.

When the medical instrument 20 is installed on the anchor device 100,the apertures 26 a-b are engaged with the stem portions 116 a-b of theanchor device 100. The relative diameters of the apertures 26 a-b andthe stem portions 116 a-b can advantageously provide for a slightly snugfit between the apertures 26 a-b and the stem portions 116 a-b. Such asnug fit can reduce the collection of contaminant materials between theapertures 26 a-b and the stem portions 116 a-b.

As will be described further below in reference to FIG. 6B, theflexibility of the wings 24 a-b can allow some limited angular freedomof movement between the hub 22 and the anchor device 100, whilegenerally restraining movement of the medical instrument 20 away fromthe skin penetration point 32. Further, the limited angular freedom ofmovement permits the hub 20 of the medical instrument 20 to be slightlytitled relative to the anchor device 100, thereby permitting the hub 20and the distal portion 28 of the medical instrument to more closelyalign with the skin penetration point 32 and reduce the stresses appliedby the medical instrument 20 at the skin penetration point 32.

Still referring to FIGS. 2A-C, the retention posts 112 a-b canoptionally include the aforementioned relief portions 118 a-b. Therelief portions 118 a-b are generally planar or slightly curved surfaceson the sides of the retention posts 112 a-b that act as material reliefareas to make it easier to remove the wings 24 a-b from retention posts112 a-b. In other words, the relief portions 118 a-b can help the userdecouple the medical instrument 20 from the anchor device 100.Specifically, the relief portions 118 a-b can allow the user to slidetheir finger along the side of the anchor device 100, to better graspthe wings 24 a-b between their thumb and forefinger, and to thereafter“peel” the wings 24 a-b off the retention posts 112 a-b. In somecircumstances, the relief portions 118 a-b can similarly facilitate theact of securing the wings 24 a-b over the retention posts 112 a-b.

Still referring to FIGS. 2A-2C, the anchor device 100 further includesfirst and second tabs 122 a-b. The first and second tabs 122 a-b areconfigured simplify the act of manipulating and folding the anchordevice 100. For example, as described further in reference to FIGS.3A-3B, the user can adjust the first and second tabs 122 a-b in apivoting motion toward one another, which readily enables the user tofold the anchor device 100 along the longitudinal fold axis 160. Thefirst and second tabs 122 a-b are also configured to provide a u-shapedcutout region 165 between the first and second tabs 122 a-b. Thisu-shaped cutout region 165 can more readily provide visualization andaccess to the skin region under the retainer body 110 for inspection andcleaning of the skin 30 around the skin penetration point 32.

The anchor device 100 also includes a sloped nose region 130. The slopednose region 130 can be a generally planar surface near the distal end ofthe retainer body 110 that is oriented at a different angle than thegenerally planar surfaces of the first and second retainer body portions120 a-b. The sloped nose region 130 can decline from the generallyplanar surfaces of the first and second retainer body portions 120 a-bsuch that the nose region 130 slopes downward in a distal directiontowards longitudinal shafts 142 a-b of the anchors 140 a-b (e.g., andthus downward to the skin penetration point 32 when the anchor tines 145a-b are deployed). As will be described further in reference to FIG. 6B,the sloped nose region 130 can facilitate an orientation of the distalportion 28 of the medical instrument 20 that is directed toward the skinpenetration point 32. In this manner, the stresses that can potentiallybe exerted on the skin 30 proximal to the skin penetration point 32 bythe distal portion 28 of the medical instrument 20 can be reduced.

As shown in FIG. 2C, the flexible web portion 150 of the anchor device100 can be positioned, for example, generally centrally between thefirst and second retainer body portions 120 a-b. As previouslydescribed, the flexible web portion 150 can extend longitudinally from adistal face of the retainer body 110 to a proximal face of the retainerbody 110, and can be used to define the fold axis 160 about which thefirst and second retainer body portions 120 a-b are pivotable from thenon-folded condition (FIG. 2A) to the folded condition (FIG. 3A). Theleft and right retainer body portions 120 a-b can be connected opposingsides of the flexible web portion 150. The flexible web portion 150 cancomprise an elastically flexible biocompatible polymer material (e.g.,silicon, PVC, polypropylene, polystyrene, or the like). In someembodiments, the flexible web portion 150 can be made of the samematerial as the other portions of the retainer body 110. In otherembodiments, the flexible web portion 150 can be made of a differentmaterial than the other portions of the retainer body 110. In such acase, the anchor device can be made, for example, using a two-stepinsert molding operation. The flexible web portion 150 can be biased toresiliently maintain the non-folded shape of the anchor device 100 asdepicted in FIGS. 2A-2C. When the anchor device 100 is folded along thefold axis 160 due to a user's grasp (refer, for example to FIG. 4), theflexible web portion 150 can undergo elastic deformation such thatflexible web portion 150 biases the anchor device 100 to return thenon-folded condition (FIGS. 2A and 5) upon release from the user.

Referring now to FIGS. 3A-3B, in this example embodiment, the anchordevice 100 may include features that allow the individual anchors 140a-b to be moved relative to each other so as to facilitate bothinsertion and removal of the anchor device 100 through the skinpenetration point 32. For example, the anchor device 100 may have afoldable configuration in which a first portion of the retainer body 110is pivotably coupled via a flexible hinge portion to a second portion ofthe retainer body 110.

More specifically, in this embodiment, the first retainer body portion120 a and the second retainer body portion 120 b can be flexibly pivotedwith respect to each other along a fold axis 160 extendinglongitudinally through the retainer body 110. To initiate the foldingprocess of the anchor device 100, the user can apply a bending momentabout the fold axis 160 to the first and second tabs 122 a-b of theanchor device. Such a bending moment can cause an elastic deformation ofthe flexible web portion 150 so as to fold the anchor device along thefold axis 160 (refer to FIG. 3A). The first retainer body portion 120 acan be fixedly coupled to the anchor 140 a, and the second retainer bodyportion 120 b can be fixedly coupled to the anchor 140 b. Thus, as shownin FIG. 3A, when the first and second retainer body portions 120 a-b arepivoted about the fold axis 160, the two anchors 140 a-b likewise pivotrelative to one another. This process of pivoting can cause the anchordevice to transition from a non-folded condition (shown in FIGS. 2A-2Cand in FIG. 1) in which the tines 145 a-b extend generally away from oneanother to a folded condition (shown in FIGS. 3A-3B), in which the tines145 a-b are generally adjacent to each other and oriented to extend insubstantially the same direction. Similarly, when the bending momentfrom the user is released, the anchor device can be biased to return theanchor device 100 from the folded condition to the non-folded condition.In the depicted embodiment, the tines 145 a-b can be rotated about75-degrees to about 105-degrees, and preferably about 90-degrees, duringthe transition between the non-folded condition and the foldedcondition. As described in more detail below, the anchor device 100 canbe arranged in the folded condition during both insertion and removal ofthe subcutaneous tines 145 a-b so as to reduce the likelihood of thetines 145 a-b causing damage to the skin 30.

Referring now to FIGS. 4-5, in some embodiments, the medical instrument20 can include a catheter to be inserted through the penetration point32 of the skin 30 as part of a medical procedure. For example, in theembodiment depicted in FIG. 1, a central venous catheter 20 can beinserted into a percutaneous opening surgically formed in the skin(e.g., penetration point 32), to the underside of the skin 30, and intoa vein 40 to provide vascular access for delivering medications orminimally invasive devices into a patient.

After placement of the catheter 20 through the penetration point 32 ofthe skin 30, the user can grasp the anchor device 100 in the foldedcondition and approach the penetration point 32 such that the free endsof the tines 145 a-b are contemporaneously inserted through thepenetration point 32 while the tines 145 a-b are in a generallyside-by-side condition (as depicted in FIG. 4). In particularembodiments, the subcutaneous tines 145 a-b are inserted through theskin penetration point 32 while the user conveniently grasps the tabs122 a-b of the retainer body 110 of the anchor device 100 and applies aninsertion force until the convexly curved body portions of thesubcutaneous tines 145 a-b are positioned below the surface of the skin30 (while the remainder of the anchor device 100 resides external to theskin 30).

As the anchor device 100 is inserted through the penetration point 32,the tines 145 a-b are maintained in a generally non-stressedconfiguration (e.g., a first shape or a steady-state shape) whilepassing through the penetration point 32 in a manner that reduces thelikelihood of trauma to the surrounding skin tissue 30. As the tines 145a-b are collectively advanced through the penetration point 32, the freeends of the tines 145 a-b are moved beneath the dermal skin layers 36 ofthe skin 30.

When the tines 145 a-b reach the subcutaneous region 34, the retainerbody 110 can adjusted to the unfolded condition so that the tines 145a-b are shifted relative to one another, resulting in the tines 145 a-bextending outwardly away from one another (as depicted in FIG. 5).During that process of unfolding the retainer body 110, each tine 145a-b may retain their generally non-stressed configuration (e.g., thefirst shape or the steady-state shape). Thus, the anchor device 100 canbe installed in accordance with a technique that reduces or eliminatesthe need to shift the subcutaneous anchors tines 145 a-b to or from aflexed or stressed configuration during the passage through the skinpenetration point 32. As such, the subcutaneous anchors tines 145 a-bneed not undergo substantial flexing during installation or removal, andin some embodiments, the subcutaneous anchors tines 145 a-b can comprisea generally less costly material (such as stainless steel orbiocompatible polymers) rather than more costly materials required forsuperelastic flexing.

As previously described, the retainer body 110 can secure the medicalinstrument 20 relative to a skin penetration point 32. With the anchordevice 100 positioned such that subcutaneous anchors tines 145 a-b arein their deployed configuration, as shown in FIG. 5, the previouslyinserted medical instrument 20 can be releasably secured to the anchordevice 100. As shown in FIG. 5, the directional arrow 200 depicts anexample motion of manually positioning the medical instrument 20adjacent to the anchor device 100 to prepare for the installation of themedical instrument 20 onto the anchor device 100.

Referring now to FIGS. 6A-B, the medical device anchor system 10 ofFIGS. 4-5 is releasably engaged with the medical instrument 20. In thisembodiment, the hub 22 of the medical instrument 20 (e.g., a catheter)may be removably attached to the retainer body 110 using one or moreapertures 26 a-b on the wings 24 a-b of the hub 22 that mechanicallyengage with corresponding retention posts 112 a-b on the retainer body110. To simplify the process of engaging the apertures 26 a-b with theretention posts 112 a-b, the hub 22 may comprise an elastically flexiblematerial, such as silicone or another biocompatible polymer material.Such flexibility can assist the user to install the medical instrument20 onto the anchor device 100 by making it possible to bend, stretch,and generally make it easy to maneuver the wings 24 a-b of the hub 22that comprise the apertures 26 a-b. In some embodiments, at least aflexible wall portion comprising the wings 24 a-b may comprise siliconeor another biocompatible polymer material so that left wing 24 a canflexibly adjust relative to a right wing 24 b, or at least to the barrelof the hub 22. In some embodiments, the hub 22 can comprise a compositematerial. That is, the wings 24 a-b may comprise silicone or anotherflexible polymer material, while the other portions of the hub 22 maycomprise a more rigid material such as a polycarbonate, PVC, or thelike. In such circumstances, the apertures 26 a-b can be aligned withand forced over the corresponding retention posts 112 a-b, andthereafter (if desired), one aperture 26 a or 26 b can be lifted fromthe retainer body 110 while the second aperture 26 b or 26 a remainssecured to the retainer body 110. With the apertures 26 a-b coupled withthe retention posts 112 a-b, the medical instrument 20 is installed onthe anchor device 100.

As shown in FIG. 6B, the anchor device 100 releasably retains themedical instrument 20 (e.g., catheter) in an operative position relativeto a portion of skin 30 (e.g., the skin penetration point 32). Themedical instrument 20 is mechanically coupled to the anchor device 100,as described above. The anchor device 100, in turn, is coupled to theportion of skin 30, as described above. In such embodiments, the anchordevice 100 can be secured to the patient without necessarily requiringsutures or adhesive tapes bonded to the skin 30. A distal portion 28 ofthe catheter 20 penetrates a skin penetration point 32 and distallyextends into the subcutaneous layer 34. In this view, it can be seenthat some embodiments of the system 10 can enable the distal end of thehub 22 to be positioned closely to the skin penetration point 32. Such aconfiguration provides a compact anchor system 10 that is convenient toinstall and maintain. This configuration can minimize the lengths of thetubing proximal to the patient, and reduce the need for securement ofsuch tubing or other portions of the medical instrument 20 to thepatient using tapes, adhesive dressings, and the like.

It can also be seen in FIG. 6B that the hub 22 of the catheter 20 mayoptionally inclined at an angle in relation to the skin surface 30. Suchan orientation between the hub 22 and the skin 30 may, in somecircumstances, reduce the stresses applied to the skin penetration point32 of the patient by the distal portion 28 of the catheter 20. Inparticular, the example orientation depicted in FIG. 6B enables thedistal portion 28 to be inclined at an angle in relation to the skinsurface 30 which can thereby reduce the need for the distal portion 28of the catheter 20 to have the a significant bend at the skinpenetration point.

Still referring to FIG. 6B, in some embodiments, the apertures 26 a-b ofthe hub 22 can have a slidable fit in relation to the stems 116 a-b ofthe retention posts 112 a-b. The slidable fit relationship can providethe hub 22 with a freedom of movement whereby the distal portion 28 willtend to position itself in relation to the skin 30 so as to naturallyminimize the amount of force applied by the distal portion 28 to theskin 30, and the sloped nose portion 130 of anchor device 100 canfurther allow the distal portion 28 to do so. For example, as describedabove in reference to FIGS. 2A-2C, the sloped nose region 130 can be aplanar surface near the distal end of the retainer body 110 that isoriented at a different angle than the generally planar surfaces of thefirst and second portions 120 a-b of the retainer body 110. The slopednose region 130 can be declined relative to the generally planar uppersurfaces of the first and second portions 120 a-b such that the slopednose region 130 slopes downward in a distal direction towards the skinpenetration point 32. Such a configuration of the anchor device 100 canallow the hub 22 of the catheter 20 to be further tilted at greaterangle relative to the skin 30 and to the anchor device 100. The slopednose region 130 can provide a material relief area that removeshindrances to the hub 22 from being positioned at an incline withrelation to the skin. The sloped nose region 130 can also provide aplanar surface to support the hub 22 in the inclined position inrelation to the skin 30. Further, in some embodiments, the retentionposts 112 a-b can have their axes oriented at an angle generallyperpendicular to the sloped nose region 130 (and thus non-perpendicularto the generally planar upper surfaces of the first and second portions120 a-b). In such a configuration, the retention posts 112 a-b canencourage the hub 22 to be inclined in relation to the skin 30 becauseof the physical interface between the retention posts 112 a-b and theapertures 26 a-b of the hub 22.

In some embodiments, some components of the system 10 can be provided ina sterilized kit that pairs a particular type of catheter 20 or othermedical instrument with a corresponding anchor device 100. Theparticular type of catheter 20 or other medical instruments in the kitis compatible for releasably mating with the retainer body 110 of theanchor device 100 in the kit. Each kit can include one or more anchordevices 100 and the particular type of catheter 20 or other medicalinstrument enclosed within a flexible packaging material, whichpreferably includes indicators that identify the type of catheter 20 orother medical instruments that is provided along with instructions fordeploying and removing the anchor device 100. The kit may include aone-to-one ratio for the quantity of anchor devices 100 to the quantityof catheters 20. In other embodiments, the kit may include multipleanchor devices 100 (e.g., having differently sized or shaped tines 145a-b) for each catheter 20 contained therein.

Alternatively, in some embodiments, the anchor device 100 can beprovided in individual, sterilized packets so that a practitioner canreadily open such a packet and access the selected anchor device priorto insertion into the skin penetration point. Such individual packetscan include a single anchor device enclosed within a flexible packagingmaterial, which preferably includes indicators that identify the typesof catheters or other medical instruments that are compatible forreleasably mating with the retainer body 110. As such, a practitionercan readily select one of the packets for use after the type of catheteror medical instrument is selected for a particular patient.

Referring now to FIGS. 7A-C and 8, some embodiments of the anchor device100 can be configured to operate in combination with an optional adaptertool 300, which permits the anchor device 100 to engage with a catheter420 or other medical instrument even if no wings (or wings of anon-corresponding size) are provided. In such embodiments, the adaptertool 300 may be configured to engage and grip an exterior of thecatheter 420 or other medical instrument while also providingsupplemental wings 324 a-b for mating with the retainer body 110 of theanchor device 100.

Referring FIGS. 7A-C, the adapter tool 300 can include a first portion322 configured to releasably couple to a catheter or other medicalinstrument and a second portion 324 a-b configured to releasably engagethe retainer body 110 of the anchor device. In this embodiment, thefirst portion of the adapter tool 300 comprises a hub 322 that defines alumen 340 with a longitudinal slit 330 through one wall of the hub 322.The longitudinal slit 330 can be flexibly opened to receive a medicalinstrument to be positioned within the lumen 340. In an exampleembodiment, the medical instrument can be a shaft 328 that issubstantially surrounded by (and, in this embodiment, full surroundedby) the lumen 340 of the hub 322 of the adapter tool 300. To illustrate,FIG. 7A shows the adapter tool 300 without a medical instrument; FIG. 7Bdepicts the installation process of placing a medical instrument (e.g.,a shaft 328 of a catheter or other medical instrument) into the lumen340 of the adapter tool 300 by elastically deforming the hub 322 towiden the longitudinal slit 330; and FIG. 7C illustrates the shaft 328installed in the adapter tool 300 such that the hub 322 fully surroundsand grips the exterior the shaft 328. In this configuration (as shown inFIG. 7C), the adapter tool 300 is prepared to be installed onto ananchor device 100.

The adapter tool 300 can comprise an elastically flexible biocompatiblepolymer material such as silicon, PVC, polypropylene, polystyrene, orthe like. In some embodiments, the adapter tool 300 can comprise acomposite structure. For example, the adapter tool 300 can have variouslayers of disparate materials. In some embodiments the adapter tool 300can have a soft durometer material (e.g., an elastomeric material suchas silicon) on the surface layer of the lumen 340 that contacts themedical instrument, and a stiffer polymer shell (e.g., polypropylene orPVC) on the upper layer (at least along the outer area of the hub 322).The softer inner layer can be bonded to a lower surface of the morerigid upper layer. Such a composite construction of the adapter tool 300can provide sufficient frictional characteristics from the inner layerto grip the medical instrument inside of the lumen 340 while the upperlayer of more rigid mater provide additional rigidity and maintains thecompression of the inner layer upon the medical instrument. Further, insome embodiments the wings 324 a-b can comprise the same material as theother portions of the adapter tool 300. In other embodiments, the wings324 a-b can comprise a different material than the other portions of theadapter tool 300, such that the wings 324 a-b have more flexibility soas to make the installation of the adapter tool 300 to the anchor devicemore convenient.

Still referring to FIGS. 7A-C, in this embodiment, the second portion ofthe adapter tool 300 comprises wings 324 a-b that extend laterallyoutward from opposing sides of the hub 322. The wings 324 a-b of theadapter tool 300 can include apertures 326 a-b. The apertures 326 a-bcan be configured to couple with retention posts of an anchor device,such as retention posts 112 a-b of anchor device 100 as described above.

The adapter tool 300 can have a variety of styles of lumens 340 so as toadapt to various types of medical devices. For example, while theexample embodiment of the adapter tool 300 shown has a lumen 340 with acircular cross-section, other configurations are envisioned, e.g.,square, oval, or triangular cross-sections, and the like. In addition,various sizes of the lumen 340 are envisioned. For example, the lumen340 can be sized to couple with tubes having various outer-diameterdimensions e.g., ¼″, 3/16″, ⅛″, 3/32″, 1/16″, as well as other sizesincluding metric sizes.

In some embodiments, a plurality of the adapter tools 300 can beprovided in a sterilized kit that provides adapters 300 having differentshapes hubs 322 that are configured to mate with different types ofcatheter 20 or other medical instruments. Preferably, the plurality ofthe adapter tools 300 packaged together in the kit can include similarwing portions 324 a-b such that any one of the plurality of the adaptertools 300 in the kit can be selected for mating with a predeterminedretainer body 110 of the anchor device 100. Each kit can includeplurality of the adapter tools 300 and, optionally, at least one of theparticular types of anchor devices 100 enclosed within a flexiblepackaging material, which preferably includes indicators that identifythe type of catheter 20 or other medical instruments that are compatiblewith the plurality of the adapter tools 300. The kit may includemultiple adapters 300 (e.g., having differently sized or shaped hubportions 322) for each anchor device 100 contained therein. As such, akit including multiple adapter tool 300 parts, with a range of differentlumen sizes and/or shapes are envisioned. In another embodiment of akit, a variety of the adapter tool 300 parts having different lumensizes and/or shapes can be included with one or more anchor devices 100designed to couple with the variety of adapter tool 300 parts. Such akit can provide practitioners with a flexible system having theequipment to handle a variety of sizes and styles of medical instrumentsthat can be anchored to a patient. In some embodiments, the kit, orindividual parts comprising the kit, may be provided in sterilepackaging.

Referring now to FIG. 8, some embodiments of an example medical deviceanchor system 400 include an anchor device 100 coupled to an adaptertool 300 that releasably retains a medical instrument 420 in anoperative position relative to a portion of skin 30 (e.g., skinpenetration point 32). The medical instrument 420 can be mechanicallycoupled to the anchor device 100 by using the adapter tool 300,especially in circumstances when the medical instrument 420 is notequipped with corresponding wings (such as the wings 24 a-b shown inFIG. 1). The anchor device 100, in turn, can be releasably anchored tothe skin penetration point 32 as described, for example, in connectionwith FIGS. 4-5 herein. In this manner, the anchor device 100 and theadapter tool 300 can act as an intermediary members to bring about theretention of the medical instrument 420 in a desired position withrespect to the skin penetration point 32.

In this embodiment, the distal portion 328 of the medical instrument 420can be percutaneously delivered in the patient via the skin penetrationpoint 32. The tines 145 a-b of anchors 140 a-b of anchor device 100 canbe inserted through the skin penetration point 32 with the anchor device100 in a folded configuration as described above in connection with FIG.4. After insertion of the anchor tines 145 a-b, the anchor device 100can be adjusted to a non-folded configuration wherein the tines 145 a-bof anchors 140 a-b are extending outwardly away from one another underthe dermal layers 36 of the patient, as described in connection withFIG. 5. The adapter tool 300 can be selected according to the type ofthe medical instrument 420 (e.g., based upon the diameter of the shaft328 in this embodiments) and thereafter releasably installed on thedistal portion 328 of the medical instrument 420, as described inconnection with FIGS. 7A-C. The adapter tool 300 can be releasablysecured onto the anchor device 100, for example, by pressing the wings324 a-b so that the apertures 326 a-b are forced onto retention posts112 a-b, as in the manner described above. It should be understood thatthe adapter tool 300 can be oriented in relation to the anchor device100 such that longitudinal slit 330 through one wall of the hub 322faces downwardly toward the anchor device 100 and is adjacent to theanchor device 100, so that the medical instrument 420 can be securelyretained in the adapter tool 300.

Referring now to FIG. 9, some alternative embodiments include an anchordevice 500 in which the position of the retention posts can be adjustedrelative to the retainer body. For example, the adjustable retentionposts 512 a-b can be selectively mounted at different positions relativeto the retainer body 110, which can provide the capability for the userto select different dimensional distances between the retention posts.This feature can enable the anchor device to mate with any of a widervariety of medical instruments. That is, in some embodiments, thepositions of the retention posts on the retainer body can be adjustableto accommodate coupling with a variety of medical instruments that havedifferent sized mounting features (e.g., such as different cathetershaving differently shaped hubs/wings). For example, certain catheterhubs may have mounting features that have a different dimensionalspacing in comparison to other catheter hubs. Having an anchor devicewith retention posts that can be adjusted to different dimensionalspacing can enable the anchor device to mate with any of a variety ofcatheter hubs. This feature can also simplify the user's selection ofanchor devices. In other words, since one anchor device can be adaptedto a wider range of medical instruments, a single anchor device can beselected and configured in accordance with the mounting features of themedical instrument immediately before deployment.

The retainer body 110 of the example anchor device 500 depicted in FIG.9 is substantially similar to the embodiments described above, but withthe addition of multiple landings 513 a-b along the upper face of theretainer body 110, so as to receive the adjustable retention posts 512a-b. Each landing 513 a-b can include a mating structure to engage witha corresponding mating structure on the adjustable retention posts 512a-b respectively. For example, in some embodiments the landings 513 a-bcan have a mating cavity that lockingly receives correspondingprojections 519 a-b on the underside of the retention posts 512 a-b(e.g., a snap-fit engagement). In other embodiments, the landings 513a-b can include threaded holes, and the corresponding projections 519a-b on the underside of the retention posts 512 a-b can include malethreads so that the retention posts 512 a-b can be screwed onto thelandings 513 a-b.

Still referring to FIG. 9, in this embodiment, the landings 513 a and513 b are configured in pairs. That is, each of the landings 513 a onthe first side has a corresponding landing 513 b on the second side, andeach of the landings 513 b on the second side has a correspondinglanding 513 a on the first side. For example, the distal-most landing513 a on the left side of the anchor device 500, corresponds to thedistal-most landing 513 b on the right side of the anchor device 500.When, for example, the distal-most landing 513 a on the left side isused to mount the adjustable retention post 512 a, then the distal-mostlanding 513 b on the right side can be used to mount the adjustableretention post 512 b. This pattern holds true for the other lessdistally located landings 513 a-b as well.

Each pair of landings 513 a-b can be spaced apart from each other at adifferent distance in comparison to the other pairs of landings 513 a-b.For instance, as depicted in the example embodiment shown in FIG. 9, thedistal-most landings 513 a-b can be a pair of landings 513 a-b that arespaced the closest together (in comparison to the other pairs oflandings 513 a-b). In contrast, the pair of landings 513 a-b locatedmost proximally on the anchor device 500 can be a pair of landings 513a-b that are spaced the farthest apart (in comparison to the other pairsof landings 513 a-b). The pairs between the distal-most and the mostproximal can separated by distances that are between the closest and thefarthest spacing distances. By selecting a suitable pair of landings 513a-b, and mounting the adjustable retention posts 512 a-b to the suitablelandings 513 a-b, the anchor device 500 can be adjusted to accommodate avariety of medical instruments that have various sizes of matingstructures. After the adjustable retention posts 512 a-b are mated withthe selected landings 513 a-b, the anchor device 500 can operate in amanner substantially similar to the configuration described inconnection with FIGS. 4-6B.

Referring now to FIG. 10, some alternative embodiments of an anchordevice 600 can be equipped with retention members that are flexible andtherefore movable with respect to the retainer body. The flexibleretention members 612 a-b may have a different shape and configurationfrom the previously described retention posts 112 a-b (FIGS. 2A-C). Suchflexibility of the retention members 612 a-b can enable the anchordevice 600 to couple with any of a variety of medical instruments havinga different of mounting interfaces. For example, while some medicalinstruments include wings with apertures, other medical instruments maybe configured with a different type of mounting interface. Providing ananchor device 600 with flexible retention members 612 a-b can enable theanchor device 600 to thereby couple with a wider variety of medicalinstruments. This feature can permit simplified user selection of anchordevices by providing a single anchor device 600 that is adaptable to awider variety of medical instruments.

As shown in FIG. 10, in some embodiments, the flexible retention members612 a-b can comprise flexible binding straps, for example, having astructure somewhat similar to cable ties. The flexible retention members612 a-b can be fixedly attached to the upper face of the retainer body,for example by insert molding, welding, gluing, clamping, and so on. Theelongate flexible portions of the flexible retention members 612 a-b canbe used to capture and secure the medical instrument 20. For example, asshown, in some embodiments the flexible retention members 612 a-b can berouted through apertures located in the wings of a catheter hub. Inother embodiments, the flexible retention members 612 a-b can be routedso as to capture the medical instrument in many other manners—such as byrouting the flexible retention members 612 a-b over flanges or otherouter surfaces, across outer surfaces in an “x” pattern, over individualtubes of a multi-tube device, and so on.

When the flexible retention members 612 a-b are engaged with the medicalinstrument (e.g., routed through apertures located in the wings of acatheter hub in the depicted embodiment), the flexible retention members612 a-b can be firmly locked in place using a receiver locking device613 a-b. In some embodiments, the receiver locking device 613 a-b can bea ratchet-type receiver mechanism that locks with a tooth surface alongthe side of the corresponding flexible retention member 612 a-b. Such aconfiguration can allow the flexible retention members 612 a-b to bepulled through the ratchet-type receiver mechanism 613 a-b in onedirection, which thereby locks the flexible retention members 612 a-btightly in place until the medical instrument 20 is released at the endof the procedure by unlocking or severing the retention members 612 a-b.As shown in the example embodiment anchor device 600, the ratchet-typereceiver mechanisms 613 a-b can be fixedly mounted to the retainer body.To lock the medical instrument 20 in place on the anchor device 600, thefree-ends of the flexible retention members 612 a-b can be routedthrough the ratchet-type receiver mechanisms 613 a-b and pulled tight.In this fashion a medical instrument can be coupled to an anchor device600 using flexible retention members 612 a-b.

In another embodiment, one flexible retention member (e.g., member 612b) can have a free-end with a pointed tip, while the other flexibleretention member (e.g., 612 a) can have a free-end with an integralratchet-type receiver mechanism. Then, after interfacing the flexibleretention members with the medical instrument, the two flexibleretention members 612 a-b can be joined together by routing the pointedtip through the ratchet-type receiver mechanism. The medical instrumentcan be secured to the anchor device by removing the slack from theflexible retention members. In this fashion a medical instrument can becoupled to an anchor device 600 using flexible retention members.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

What is claimed is:
 1. An anchor device for securing the position of amedical instrument, the anchor device comprising: a retainer bodycomprising a first body portion that is pivotably coupled to a secondbody portion about a longitudinal fold axis; and first and secondanchors that extend distally from a distal end of the retainer body,each anchor comprising a flexible tine that is deployable in asubcutaneous region to secure the retainer body relative to apenetration point, the first anchor being coupled to the first bodyportion and the second anchor being coupled to the second body portion,wherein the first body portion of the retainer body is pivotablerelative to the second body portion about the longitudinal fold axis sothat the first and second anchors are adjustable from a firstconfiguration in which the flexible tines extend outwardly away from oneanother to a second configuration in which the flexible tines extendgenerally in a same direction; and wherein the first body portion andthe second body portions define a cutout region therebetween at aproximal end opposite from the first and second anchors in the firstconfiguration to provide visualization and access to a surface under theretainer body.
 2. The anchor device of claim 1, wherein the retainerbody comprises one or more anchor engagement portions configured toreleasably receive one or more corresponding apertures defined by a hubof a catheter.
 3. The anchor device of claim 2, wherein the one or moreanchor engagement portions comprise one or more retention posts thatextend upwardly from the retainer body.
 4. The anchor device of claim 3,wherein the one or more retention posts extend from the retainer body atan angle that is generally transverse to the longitudinal fold axis. 5.The anchor device of claim 3, wherein the one or more retention postsare positioned along a perimeter of the retainer body.
 6. The anchordevice of claim 5, wherein the one or more retention posts comprise afirst retention post extending upwardly from the retainer body on afirst side of the longitudinal fold axis and a second retention postextending upwardly from the retainer body on a second side of thelongitudinal fold axis.
 7. The anchor device of claim 6, wherein theflexible tines of the first and second anchors have a convex curvaturefacing towards the body portions.
 8. The anchor device of claim 3,wherein the retention post comprises a stem portion that is connected tothe retainer body and that has a first lateral width, and a bulbous endportion that has a second lateral width greater than the first lateralwidth of the stem portion.
 9. The anchor device of claim 1, wherein theretainer body comprises a flexible web portion positioned generallycentrally between the first and second body portions and extendinglongitudinally from the distal end of the retainer body to a proximalface of the retainer body, wherein the flexible web portion defines thelongitudinal fold axis.
 10. The anchor device of claim 1, wherein theretainer body comprises a sloped nose region having a generally planarupper surface that is oriented at a decline angle extending distallyfrom generally planar surfaces of the first and second body portions.11. The anchor device of claim 10, wherein the flexible tines of thefirst and second anchors have a convex curvature facing towards the bodyportions.
 12. An anchor device for securing the position of a medicalinstrument, the anchor device comprising: a retainer body comprising afirst body portion that is pivotably coupled to a second body portionabout a longitudinal fold axis; and first and second anchors that extenddistally from a distal end of the retainer body, each anchor comprisinga flexible tine that is deployable in a subcutaneous region to securethe retainer body relative to a penetration point, the first anchorbeing coupled to the first body portion and the second anchor beingcoupled to the second body portion, wherein the first body portion ofthe retainer body is pivotable relative to the second body portion aboutthe longitudinal fold axis so that the first and second anchors areadjustable from a first configuration in which the flexible tines extendoutwardly away from one another to a second configuration in which theflexible tines extend generally in a same direction; and wherein thefirst body portion and the second body portions define a cutout regiontherebetween in the first configuration to provide visualization andaccess to a surface under the retainer body; wherein the first andsecond body portions include first and second tabs, respectively, at aproximal end of the retainer body, wherein the first and second tabsdefine the cutout region.
 13. The anchor device of claim 12, wherein theone or more retention posts are positioned along a perimeter of theretainer body between the cutout region and the first and secondanchors.
 14. A system for securing the position of a medical instrument,the system comprising: an adapter including: a hub portion that iselastically deformable and configured to substantially surround andreleasably engage with an outer surface of a medical instrument, and asecond portion having one or more engagement members extending outwardlyfrom the hub portion; and an anchor device comprising: a retainer bodycomprising a first body portion that is pivotably coupled to a secondbody portion about a longitudinal fold axis, and one or more anchorengagement portions being configured to releasably couple with the oneor more engagement members extending outwardly from the hub portion ofthe adapter; and first and second anchors that extend distally from adistal end of the retainer body, each anchor comprising a flexible tinethat is deployable in a subcutaneous region to secure the retainer bodyrelative to a penetration point, the first anchor being coupled to thefirst body portion and the second anchor being coupled to the secondbody portion, wherein the first body portion of the retainer body ispivotable relative to the second body portion about the longitudinalfold axis so that the first and second anchors are adjustable from afirst configuration in which the flexible tines extend outwardly awayfrom one another to a second configuration in which the flexible tinesextend generally in a same direction; and wherein the first body portionand the second body portions define a cutout region therebetween at aproximal end opposite from the first and second anchors in the firstconfiguration to provide visualization and access to a surface under theretainer body.
 15. The system of claim 14, wherein the hub portion ofthe adapter comprises a longitudinal slit that is configured to open toreceive a portion of the catheter.
 16. The system of claim 14, whereinthe one or more anchor engagement portions each comprise a retentionpost that extends from the retainer body at an angle that is generallytransverse to a longitudinal fold axis.
 17. The system of claim 16,wherein the retention post comprises a stem portion that is connected tothe retainer body and that has a first lateral width, and a bulbous endportion that has a second lateral width greater than the first lateralwidth of the stem portion.
 18. The system of claim 17, wherein thebulbous end portion comprises a substantially planar face on one side ofthe bulbous end portion.
 19. The system of claim 16, wherein the secondportion of the adapter comprises one or more apertures that areconfigured to receive the retention post of the one or more anchorengagement portions.
 20. The system of claim 19, wherein the hub isconfigured to be tilted relative to the anchor device when the retentionpost of the one or more engagement portions is received by the one ormore apertures.
 21. The system of claim 20, wherein the retainer bodyfurther comprises a sloped nose region having a generally planar uppersurface that is oriented at a decline angle extending distally fromgenerally planar surfaces of the first and second body portions.